QA ASSOCIATE, REGULATORY COMPLIANCE SPECIALIST

Seattle, Washington, United States

SUMMARY:

The QA ASSOCIATE III (REGULATORY COMPLIANCE SPECIALIST) is responsible for ensuring compliance with internal SOPs and applicable regulatory guidelines and requirements.  This role requires attention to detail, organization, multi-tasking, and ability to interact with people who might be junior or senior to the incumbent.

PRINCIPAL RESPONSIBILITIES:

• Support with Regulatory Inspection Readiness

• Inspection Preparedness

• Maintain inspection readiness through inspection preparedness program and periodic readiness verification

• Execute against plan (training, document readiness, response preparation and readiness)

• Maintaining the Quality Systems in compliance with cGMP, FDA and ICH applicable regulations.

• Provide support to other functional areas for dealing with Deviations, CAPA, Change Control, Complaints and Recalls.

• Create and update SOPs, company Policies and other GMP documents.

• Support the internal audit program

• Maintain the internal audit schedule

• Coordinate with internal auditors

Support the program to pro-active management of clients to ensure confidence in Quality systems including:

• Support establishing Quality Agreements with clients consistent with Global standard.
• Ensure communications with client are maintained consistent with Quality Agreement and positive client experience
• Support required client audits and provide observation responses consistent with timeline commitments
• Support Compliance Documentation and Licensing

Establish a calendar to provide visibility to compliance documentation requirements

Generate and provide required documentation to clients and Regulatory authorities

Other duties, as assigned.

KNOWLEDGE, SKILLS & ABILITIES:

• Strong understanding of cGMP's and concepts in several quality systems.
• Demonstrated ability to work on moderately complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
• Demonstrated knowledge of GMP, GCP and both US and foreign regulations (EU, IPAC, ICH) is required.
• Strong oral and written communication skills.
• Ability to negotiate needed actions and manage difficult interactions effectively.
• Knowledge of computerized support tools and software for audit tracking and reporting.
• Demonstrated knowledge of root cause/trend analysis/risk analysis.
• Demonstrated knowledge of quality processes and compliance.
• Demonstrated ability to multi-task and work on several projects and problems
• Ability to work under only general direction
• Ability to independently determine and develop approach to solutions

EDUCATION/EXPERIENCE:

• BA/BS in Biology, Chemistry or similar Science education. MS degree preferred
• 5+ years QA or related experience working in a regulatory environment or position (GLP, GCP or GMP) with a minimum of 3 years of experience within Biopharmaceutical industry
• Prior auditing experience preferred